Merck Caught Misrepresenting Vioxx Risks Again

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[sSRI-Research] Pringle - Merck Caught Misrepresenting Vioxx

Risks Again

 

 

 

Merck Caught Misrepresenting Vioxx Risks Again *

 

*May 17, 2006.

By Eveyln Pringle*

 

 

Although Merck has long maintained that the risks associated with Vioxx

occur after long-term use, a recent study in the Canadian Medical

Association Journal, says the drug may raise the risk of heart attack

for patients taking Vioxx for less than 2 weeks.

 

The study published online this month, found that more than 25% of 239

patients who had heart attacks did so in less than 13 days of being on

the drug.

 

The study followed patients for about two and a half years and included

30,200 Vioxx users and 45,000 Celebrex patients. It found no

statistically significant increase in heart attack risk with Celebrex

patients.

Evelyn Pringle

 

In addition, on May 12, 2006, Dr Steven Nissen, interim chairman of

cardiology at the Cleveland Clinic in Ohio, said Merck recently

misrepresented an analysis of data from a follow-up review of patients

who participated in the 3-year study called, Approve, that led to Vioxx

being pulled off the market on September 30, 2004.

 

" It's important that we inform people about this because patients who

have taken the drug will need increased surveillance by their physicians

and increased awareness of their risks in the year subsequent to

stopping the drug. And that risk may extend beyond a year; we simply

don't know, " Nissen told Reuters in a telephone interview.

 

" In the one year after Vioxx was stopped there was a 75 percent greater

risk of having an adverse event, " he said.

 

" What this means is that, surprisingly, in the year following

discontinuation of Vioxx the relative risk remains approximately as high

as it was when people were actually taking the drug, " Dr Nissen

explained. " That is very clear from the data, " he said.

 

Critics say the cozy relationship between the pharmaceutical industry

and the FDA is evidenced by the large number of industry connected

members on the agency's advisory panels. A study conducted by the Public

Citizen's Health Research Group in the April 26, 2006 issue of the

Journal of American Medical Association analyzed the transcripts of 221

FDA drug advisory panel meetings that involved 16 committees, listed on

the agency's web site as taking place between January 1, 2001 and

December 31, 2004.

 

The analysis revealed that in 73% of the meetings, at least one member

of the panel or one voting consultant disclosed a conflict, and yet only

1% of the members recused themselves from participating.

 

In all, 28% of committee members and voting consultants disclosed a

conflict, the most common involving substantial financial dealings from

consulting agreements, contracts or grants, and investments. For

instance, the study found that 19% of the consulting agreements were

worth over $10,000, 30% of the investments involved over $25,000, and

23% of contracts or grants exceeded $100,000.

 

In the case of Vioxx, ten of the 32 members on the FDA advisory

committee that voted to allow the continued sale of Cox-2 pain drugs,

including Vioxx, had previously acted as paid consultants for the drugs'

manufacturers.

 

And true to form, the members with industry ties voted to return Vioxx

to the market. Dr Marcia Angell, a senior lecturer in social medicine at

Harvard Medical School and author of ''The Truth About the Drug

Companies: How They Deceive Us and What to Do About It, " said in a March

10, 2005 editorial in the Boston Globe: " It is hard to see how the panel

could have concluded that the benefits were worth those risks,

especially given the fact that taking over-the-counter Prilosec in

addition to an older pain reliever would probably have provided as much

protection from stomach ulcers. "

 

Dr Angell says advisory committees should not include paid consultants

for drug companies. " Their conflict of interest is real, not

''potential, " she wrote.

 

" The excuse that they are indispensable, " she says, " is not only

self-serving but insulting to the experts who don't consult for industry. "

 

However, in what critics call a rare occurrence, and no doubt because

the agency was under intense public scrutiny, in this instance the FDA

did not follow the recommendation of its advisory panel and Vioxx was

not approved for a return to the market.

 

In light of the evidence of Merck's total disregard for patient health

that has surfaced in Vioxx litigation thus far, the public needs to take

a good hard look at any proposed legislation or action by Congress or

the FDA that would shield drug companies from accountability based on

the FDA's approval of a drug.

 

According to Attorney, Karen Barth Menzies*, a partner in the Los

Angeles based Baum Hedlund law firm, " the Vioxx public health debacle,

has served to highlight deep-seeded problems within the FDA. "

 

She says, " drug companies are profit-driven and are loath to issue

warnings about risks associated with their drugs, even those that become

quite clear. "

 

" And it is precisely for this reason, " Ms Menzies says, " that the public

is in such desperate need for an agency that advocates for them, rather

than the drug industry. "

 

The FDA played a big part in the Vioxx disaster and allowed Merck to get

away with murder. A new report released on April 24, 2006, by the

Government Accountability Office is deeply critical of the FDA's

approach to drug safety and specifically Vioxx, and lists organizational

dysfunction, bureaucratic politics, and ineffective enforcement over

drug companies as factors compromising drug safety.

 

The report was commissioned by Senator Charles Grassley (R-Iowa), in

response to findings at a November 18, 2004, Senate Finance Committee

hearing titled, " FDA, Merck and Vioxx: Putting Patient Safety First, "

where reports of mismanagement surfaced regarding the FDA's failure to

implement safety measures to protect the public against the dangers of

Vioxx.

 

Citing " recent controversy about drug safety, " the report illuminates

the weaknesses of the FDA in monitoring the safety of drugs once they

are approved.

 

The report states that the FDA " lacks a clear and effective process for

making decisions about, and providing management oversight of,

postmarket drug safety issues. "

 

It highlights the communication problems between the two FDA offices

that handle postmarket safety concerns and advises that " insufficient

communication " between the Office of Drug Safety and the Office of New

Drugs " has hindered the decision-making process. "

 

" Specifically, " the GAO wrote, " ODS management does not always know how

OND has responded to ODS's safety analyses and recommendations. "

 

Ms Menzies says the FDA has sided with industry for years. " The recent

GAO report, " she says, " confirms many of the problems that we have been

shouting about for years and illustrates that, contrary to FDA's

preemption arguments, FDA's decisions must be second-guessed for the

safety of the public. "

 

The report comes almost two years after the hearing that revealed the

FDA had not acted promptly to protect the public when it first became

aware of information that Vioxx might pose risks to cardiovascular health.

 

The Senate Finance Committee got involved in the Vioxx matter because it

has jurisdiction over the Medicare and Medicaid programs. " Accordingly, "

Senator Grassley informed the audience at the start of the November 18,

2004 hearing, " the committee has a responsibility to the more than 80

million Americans who receive health care coverage --- including

prescription drugs --- under these programs. "

 

" Of the 20 million Americans who reportedly took Vioxx, an untold number

are Medicare and Medicaid beneficiaries, " he advised. " I was told that

the Medicaid program paid in excess of $1 billion for Vioxx while Vioxx

was on the market, " he said.

 

To demonstrate the value of government payments to Merck, at the

beginning of the hearing, Senator Grassley described a June 4, 1999

Merck document titled " IN IT TO WIN IT " that said: " As of yesterday,

Vioxx became reimbursable on Medicaid in 42 states with the other 8

states close behind. "

 

" The Medicaid market was clearly going to be a money maker for Merck, "

he said, " and Medicaid has paid Merck well for Vioxx. "

 

When the FDA approves a drug, Senator Grassley said, it's considered a

" Good Housekeeping Seal of Approval. "

 

" However, " he told the audience, " what's come to light about Vioxx since

September 30th makes people wonder if the FDA has lost its way when it

comes to making sure drugs are safe. "

 

It looks like the FDA, he said, allowed itself to be manipulated by

Merck on labeling changes that became necessary after a review by Merck

that's known as the VIGOR trial.

 

He explained how Merck completed the VIGOR trial in March 2000 and gave

the findings to the FDA in June 2000, and was the subject of an advisory

board meeting in February 2001. " But it was April 11, 2002, " he told the

audience, " before the Vioxx label was actually changed. "

 

" During these 22 months, " Senator Grassley said, " Merck aggressively

marketed Vioxx, knowing that consumers and doctors were largely unaware

of the cardiovascular risks found in the VIGOR trial. "

 

The bottom line is, consumers should not have to second guess the safety

of what's in

their medicine cabinets, " he said. " The public should feel confident

that when the FDA approves a drug, you can bank on it being safe, and if

a drug isn't safe, the FDA will take it off the market. "

 

The first witness called to testify at the hearing, was Dr David Graham,

a scientist with an 18 year career at the FDA, who blew the whistle on

the FDA' s handling of the safety issues related to Vioxx.

 

Right off the bat, he warned the committee: " we, are faced with what may

be the single greatest drug safety catastrophe in the history of this

country or the history of the world. "

 

He called the Vioxx tragedy " a profound regulatory failure. "

 

" It is important, " Dr Graham said, " that this Committee and the American

people understand that what has happened with Vioxx is really a symptom

of something far more dangerous to the safety of the American people. "

 

" Simply put, " he told the panel, " FDA and its Center for Drug Evaluation

and Research are broken. "

 

Dr Graham discussed the studies that demonstrated that Merck and the FDA

were aware of the Vioxx risks since before the drug was approved.

 

He told the panel of a Merck study named 090, that found a nearly 7-fold

increase in heart attack risk with low doses of Vioxx conducted before

the drug was approved and yet the labeling at the time of FDA approval

said nothing about the risks.

 

In November 2000, he said, the VIGOR study found a 5-fold increase in

heart attack risk with high-doses of Vioxx and yet the company said

Vioxx was safe.

 

In fact, it was not until about 18 months after the VIGOR trial was

published, that the FDA made a label change to include the heart attack

risk, but even then the agency did not place it the " Warnings " section.

 

" Of note, " Dr Graham told the committee, " FDA's label change had

absolutely no effect on how often high-dose Vioxx was prescribed, so

what good did it achieve? "

 

He informed the panel that a large study in 2002 also reported a 2-fold

increase in heart attack risk with high-doses of Vioxx.

 

In March of 2004, he said another study determined that both high-dose

and low-dose Vioxx increased the risk of heart attack and sudden death.

 

In this study, users of Vioxx were compared with users of another COX-2

inhibitor, Celebrex. The analysis found that Vioxx at doses of 25 mg or

less daily was associated with a 50% increase in the risk of heart

attack; and doses of greater than 25 mg daily were associated with a

370% increase in the risk of heart attacks.

 

Yet a report describing these findings was not posted on the FDA website

until November 2004, on election day.

 

" In my opinion, " Dr Graham said, " the FDA has let the American people

down, and sadly, betrayed a public trust. "

 

In regard to injuries, Dr Graham told the panel that Dr Eric Topol of

the Cleveland Clinic estimated that there were up to 160,000 cases of

heart attacks and strokes due to Vioxx, in an article published in the

New England Journal of Medicine.

 

" This article, " Dr Graham said, " lays out clearly the public health

significance of what we're talking about today. "

 

At the November 18, 2004 hearing, to illustrate the significance of

100,000 people being affected by Vioxx, Dr Graham presented charts to

show that when looking at Florida or Pennsylvania, it would mean that 1%

of the entire population would have been affected. For Iowa, the charts

showed it would be 5%, for Maine 10%, and for Wyoming 27%.

 

" If we look at selected cities, " Dr Graham told Senator Grassley who

resides in Des Moines, Iowa, " 67% of the citizens of Des Moines would be

affected, and what's worse, " he continued, " the entire population of

every other city in the State of Iowa. "

 

The VIGOR study started in January 1999, and included patients over 40,

with rheumatoid arthritis who were given either Vioxx or Naproxen.

Patients with recent cardiovascular events and patients taking aspirin

were excluded from the study.

 

In the combined outcome of all cardiovascular deaths, heart attacks and

strokes, Vioxx patients had higher rates than Naproxen patients. For the

outcome of heart attack alone, the rate was five times higher in Vioxx

patients than in Naproxen patients

 

In 1000 patients followed for one year, Vioxx treatment was found likely

to be associated with 6 more heart attacks than Naproxen treatment.

 

Dr Graham said he became concerned about the public health risk after

the VIGOR study indicated that the heart attack risk was increased

5-fold in patients who used the high-dose strength of Vioxx.

 

The safety question was important he explained because (1) Vioxx would

be used by millions of patients; (2) heart attack is a fairly common

event; and (3) even a small increase in risk could mean that tens of

thousands of patients might be seriously harmed or killed.

 

" If these three factors were present, " Dr Graham said, " I knew that we

would have all the ingredients necessary to guarantee a national

disaster. "

 

To get answers, he worked with Kaiser Permanente in California to

perform a study that took nearly 3 years to complete and concluded that

high-dose Vioxx significantly increased the risk of heart attacks and

sudden death and should not be prescribed or used by patients.

 

" This conclusion, " Dr Graham said, " triggered an explosive response from

the Office of New Drugs, which approved Vioxx in the first place and was

responsible for regulating it postmarketing. "

 

The response from senior management in the Office of Drug Safety was

equally stressful he said. " I was pressured to change my conclusions and

recommendations, " he told the panel, " and basically threatened that if I

did not change them, I would not be permitted to present the paper at

the conference. "

 

In fact, one Drug Safety manager recommended that he should be barred

from presenting the poster at the meeting, and also said that Merck

needed to know about the study results.

 

Finally, he said they wrote a manuscript for publication in a

peer-reviewed medical journal and senior managers in the Office of Drug

Safety would not grant clearance for its publication, even though it was

accepted by a prestigious journal after rigorous peer review.

 

" Until it is cleared, " Dr Graham told the panel, " our data and

conclusions will not see the light of day in the scientific forum they

deserve and have earned, and serious students of drug safety and drug

regulation will be denied the opportunity to consider and openly debate

the issues we raise in that paper. "

 

As for the FDA conduct in responding to the studies that showed the

dangers of Vioxx, Dr Graham discussed what he referred to as two

" revelatory milestones, " in 2004.

 

" In mid-August, " he said, " despite our study results showing an

increased risk of heart attack with Vioxx, and despite the results of

other studies published in the literature, FDA announced it had approved

Vioxx for use in children with rheumatoid arthritis. "

 

" Also, on September 22, " he told the committee, " at a meeting attended

by the director of the reviewing office that approved Vioxx, the

director and deputy director of the reviewing division within that

office and senior managers from the Office of Drug Safety, no one

thought there was a Vioxx safety issue to be dealt with. "

 

At this meeting, the reviewing office director asked Dr Graham why he

had even thought to study Vioxx and heart attacks because the FDA had

made its labeling change and nothing more needed to be done.

 

At the same meeting, a senior manager from ODS labeled the latest Vioxx

study conducted by Dr Graham's team, " a scientific rumor. "

 

" Eight days later, " Dr Graham told the panel, " Merck pulled Vioxx from

the market. "

 

" My experience with Vioxx is typical of how CDER responds to serious

drug safety issues in general, " he said.

 

On December 31, 2004, Dr Graham told Inter Press Service that the Vioxx

debacle did not phase the FDA. " You have an agency in denial, " he said

in the interview with IPS, " the FDA still maintains it made no mistake

in the approval or regulation of Vioxx. "

 

He said, " intimidation of scientists who threaten the status quo at FDA

is routine, " and described how, his FDA superior reacted after he sought

withdrawal of another arthritis drug called Arava.

 

" The division director spent the first 10 minutes of that meeting

screaming at me, " he said. " Basically, standing up, jugular veins

bulging in his neck, eyes sort of bugging out of his head, screaming, "

he recalled, " basically trying to intimidate me so that I'd change my

conclusion. "

 

In fact, once Dr Graham went public, history shows that there was a

full-court press by FDA officials against the agency Whistleblower.

 

Dr Steven Galson, the acting director of the FDA drug-evaluation

division at the time, told reporters that Graham's work " constitutes

junk science, " and sent an email to an editor at the British medical

journal The Lancet, questioning the " integrity " of Dr Graham's data.

 

Acting FDA commissioner, Dr Lester Crawford, accused Dr Graham of

evading the agency's " long-established peer review and clearance

process, " and another agency official made calls to a Senate staffer,

disparaging Dr Graham personally and professionally.

 

Before the testimony even began at the November 18 hearing, Senator

Grassley responded to comments issued the night before by Dr Crawford

against Dr Graham.

 

" News reports today, " Senator Grassley noted, " say the FDA is calling

Dr. Graham a " a maverick who did not follow Agency protocols. "

 

Dr. Graham, he explained, completed an FDA sponsored three-year study

under FDA guidance and with Drs. Campen, Levy, Shoor, Ray, Cheetham,

Spence and Hui. Dr. Graham's immediate supervisor said the paper that

formed the basis of the study was " ... an excellent study and analysis

of a complex topic. "

 

" So the clarifications provided last night by Dr. Crawford, " Senator

Grassley said, " appear intended to intimidate a witness on the eve of

hearing. "

 

Dr Crawford knows there's a problem, he told the audience, " and would

better serve the FDA by spending time on the problem rather than going

after congressional witnesses who helped identify the problem in the

first place. "

 

Earlier in the year, on March 10, 2005, Senator Grassley gave a speech

to the Consumer Federation of America and praised the FDA whistleblower

and described how the FDA stonewalled concerns raised by Dr Graham after

a study found an increased risk of heart attacks and strokes with Vioxx

and said:

 

" Dr. Graham warned the FDA of the cardiovascular risks of Vioxx, the FDA

approved the use of Vioxx for children. The director of FDA's office of

new drugs suggested that Dr. Graham water down his Vioxx conclusions.

Dr. Graham replied that in good conscience he could not. When Dr. Graham

was asked to present his findings at my committee's Vioxx hearing, he

was also undermined.

 

" Dr. Graham did testify before the advisory committee and his science

was subjected to public scrutiny from his peers. ... In the end, the

scientific process prevailed. But again, not before Dr. Graham's

supervisors attempted to intercede. "

 

In the speech, Senator Grassley said FDA whistleblowers are patriots.

 

" Think about the guts it takes to undermine your career, " he said, " and

to go against your supervisors at a huge federal agency, and in this

case, the multi-billion-dollar drug companies. "

 

" Whistleblowers are the rare birds who refuse to go along to get along, "

he told the audience. " The only thing they're guilty of is " committing

truth, " he said.

 

" Unfortunately, " Grassley told the audience, " it appears that some drug

companies are placing greed ahead of drug safety. In this fraudulent

environment, the FDA's mission is more important than ever before. The

FDA absolutely has to do a top-notch job on ensuring drug safety, " he

said.

 

The FDA " needs to demonstrate that it is unequivocally committed to the

scientific process -- and those who speak up on its behalf -- when it

comes to drug safety and that nothing gets in the way of that, whether

it's pressure from profit-oriented drug makers or institutional ego that

doesn't want to admit a mistake, " Grassley warned.

 

" The one and only client of the FDA must be John Q. Public, " he declared.

 

Four months later, on July 18, 2005, Senator Grassley took to the floor

of the Senate to explain why he would vote against the nomination of Dr

Crawford to head the FDA, and gave a caustic speech about the FDA's

relationship with drug companies as a whole, and Dr Crawford's conduct

in the position of a temporary commissioner, and said in part:

 

" During the last 18 months, this country's confidence in the FDA has

been shaken. It has been shaken not because of one isolated incident or

one isolated whistleblower. It has been shaken because multiple drug

safety concerns have been exposed by more than one courageous

whistleblower.

 

" My oversight of the FDA leads me to the conclusion that there are

cultural and systemic problems at the FDA. Unfortunately, Dr. Crawford

has long been part of that same culture and system. The evidence is

overwhelming that the FDA must change to better protect the American

people. Dr. Crawford does not appear willing to be the man to change the

FDA.

 

" During Dr. Crawford's tenure, I have witnessed the suppression of the

scientific process and the muzzling of scientific dissent. First, with

Dr. Mosholder finding a link between anti-depressants, children and

suicide. And second with Dr. Graham's allegations regarding the FDA,

Vioxx and post-marketing safety generally.

 

" Dr. Graham's testimony before the Finance Committee suggests that the

problems are systemic. Oversight of the FDA exposed the cozy

relationship that exists between the FDA and the drug industry. It

revealed that the FDA negotiated for almost two years with Merck about

how to change the Vioxx label so people would know about the risk of

heart attacks. "

 

In the end, Dr Crawford did become the FDA Commissioner in July 2005,

but not for long. This Lester Crawford saga gives to new meaning to the

phrase of " what goes around comes around. "

 

After less than 3 months on the job, in a September 23, 2005 letter to

President Bush, Crawford announced his resignation from the FDA and said

it was " effective immediately. "

 

In public, Crawford explained his departure by saying it was time for

someone else to lead the agency. On September 28, 2005, Forbes.com

reported that Crawford said he decided to leave the agency because he

was tiring after three years at the agency. " He denies that financial

conflicts of interest had anything to do with his decision to resign, "

Forbes noted.

 

However, Senators Mike Enzi (R-Wyo) and Edward Kennedy (D-Mass) disputed

that claim and asked the HHS Inspector General to investigate Crawford's

resignation to see whether he left due to an undisclosed financial

conflict of interest.

 

Less than a month later, on October 26, 2005 the Wall Street Journal

reported that as late as 2004, Crawford or his wife " owned stock in

companies that make or distribute products regulated by the agency. "

 

According to the Journal, Crawford or his wife held shares in several

companies whose business is regulated by the FDA, as late as 2004, when

Crawford was acting commissioner, quoting financial disclosure forms

obtained by the Journal.

 

When Crawford began work at the FDA in 2002, the Journal said, he held

stock in many companies, including Merck, Pfizer, and Johnson and

Johnson. But he told ethics officials that he sold those stocks in 2002,

along with stock he held in Kimberly-Clark, which makes medical devices.

 

Crawford also reported the sale of his stock in the company Teleflex Inc

in 2002, which also makes medical devices, although " later forms show

that he or his wife continued to own some shares, " the Journal reports.

 

On the same day that the Journal's article was published, the Kaiser

Daily Health Policy Report reported that the HHS Inspector General had

confirmed that it had launched an investigation into Crawford's

departure from the FDA.

 

About 3 months after that, on February 8, 2006, Crawford's new employer

was revealed when the Washington Post reported that Crawford, " whose

sudden resignation last fall after less than three months in office

remains a mystery, has joined a lobbying firm that specializes in food

and drug issues. "

 

" Crawford is listed as " senior counsel " to the firm Policy Directions

Inc. " the Post said.

 

A few of the firm's clients listed in the article, include Merck, Altria

Group Inc, formerly Philip Morris Companies, and the industry's trade

group, the Pharmaceutical Research and Manufacturers of America.

 

According to the Post, " Crawford is barred from lobbying former

colleagues at the FDA for a year, but he can give clients strategic

advice about food and drug issues and can lobby members of Congress. "

 

Less than a month later, on March 3, 2006, the Houston Chronicle

reported that before he abruptly resigned, Crawford sold more than

$50,000 in shares of Teleflex Inc, " a company that makes medical

devices, according to financial disclosure forms " obtained by The

Associated Press.

 

" As head of the FDA, " the Chronicle noted, " Crawford oversaw the

regulation of medical devices. "

 

And on April 29, 2006, the Washington Post reported that the " former

commissioner of the Food and Drug Administration is under federal

investigation amid accusations of financial improprieties and making

false statements to Congress. "

 

The criminal investigation was disclosed at a hearing in a civil suit

filed against the FDA over its handling of the emergency contraceptive

Plan B, according to the Wall Street Journal on May 1, 2006. It seems

Crawford was scheduled to be questioned under oath in the trial, but his

attorney Barbara Van Gelder asked for a delay, saying she would instruct

Crawford to invoke his Fifth Amendment rights.

 

Van Gelder said that Crawford is under criminal investigation and that

the issue of his financial disclosures " is within the grand jury. "

 

As for how things are going these days for Dr Graham, in April 2006, he

was interviewed by Life Extension Magazine and described his life as

" surreal " since the Vioxx scandal broke and discussed what its like to

face the same people every day who tried to destroy him for simply

telling the truth.

 

" It's very difficult, " he said. " I periodically have to sit down with

supervisors who I knew in November were lying to Congress about me,

lying to The Lancet about me, and who tried to prevent my getting

protection as a government whistleblower. "

 

" They were doing hateful things, " he explained, " and now they pretend

nothing happened. "

 

Dr Graham did say that the mistreatment comes only from senior

management. " At the staff level, " he said, " I'm very respected and

supported. "

 

" If anything, esteem for me has increased because they realize I told

the truth, " he told Life Extension. " They know the reality of what we're

dealing with. "

 

In April 2006, in what has to be one of Merck's worst nightmares, a

federal judge ordered Dr Graham to testify at a deposition in the Vioxx

multidistrict litigation. The MDL was created to consolidate pretrial

proceedings for the thousands of lawsuits filed by users of Vioxx.

 

The FDA attempted to block Dr Graham's testimony by filing a motion to

quash the Plaintiff's subpoena on grounds that his deposition would

divert the agency's time and resources, and cripple its ability to

fulfill its statutory mandate, and said there was no need to depose Dr

Graham, given his public statements already made.

 

However, Judge Eldon Fallon denied the motion and said: " This court does

not see how the deposition of one employee during nonworking hours would

cripple the FDA's ability to function. "

 

He also noted that none of the documents in the public record could

" express Dr. Graham's opinion with the clarity and tone as he personally

can in his deposition. "

 

 

* Karen Barth Menzies and writer Evelyn Pringle are members of our group.

 

*